SHM Converge Scientific Abstract ePoster Gallery-Safety of Investigational Microbiota-Based Live Biotherapeutic Rbx2660 in Individuals With Recurrent Clostridioides Difficile Infection: Data From 5 Prospective Clinical Studies

Safety of Investigational Microbiota-Based Live Biotherapeutic Rbx2660 in Individuals With Recurrent Clostridioides Difficile Infection: Data From 5 Prospective Clinical Studies

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This presentation summarizes pooled safety data for RBX2660, an investigational microbiota-based live biotherapeutic being studied to prevent recurrent Clostridioides difficile infection (CDI). CDI is a major global health burden, and standard antibiotic treatment can disrupt the gut microbiome, contributing to recurrence.<br /><br />Safety data were pooled from five prospective studies (three phase 2 and two phase 3) including 832 adults with recurrent CDI who had already received standard-of-care antibiotics. Participants received either placebo or RBX2660 as one dose or two doses one week apart, with follow-up through six months. Some studies also allowed open-label RBX2660 retreatment after recurrence.<br /><br />Of the 832 participants, 749 received at least one dose of RBX2660 and 83 received placebo only. Those treated with RBX2660 tended to be older and had more prior CDI episodes than placebo-only participants. Overall, 68.6% of participants experienced at least one treatment-emergent adverse event (TEAE). Most TEAEs were mild or moderate and were commonly related to preexisting conditions. Gastrointestinal events were the most frequent, including diarrhea, abdominal pain, nausea, and flatulence.<br /><br />Serious adverse events occurred in 14.2% of the all-RBX2660 group. Discontinuations due to adverse events were rare, occurring in 7 of 749 RBX2660-treated participants (0.9%). No potentially life-threatening TEAEs were considered related to RBX2660. One death assessed as possibly related to the product and enema procedure was reviewed and determined not to represent a product-related safety concern.<br /><br />Overall, the pooled data indicate that RBX2660 has a well-characterized safety profile and is generally well tolerated, supporting its continued development as a potential option to reduce recurrent CDI.

Asset Subtitle

Adam Harvey

Meta Tag

Author List Adam Harvey, Beth Guthmueller, Tricia Braun

Category Research

Concept RBX2660

Concept Safety Profile

Concept Adverse Event

Concept Treatment-Emergent Adverse Event

Concept Severe adverse effect

Distinguished Non-Finalist

Presenter Organization Rebiotix Inc, a Ferring Company

Presenting Author Adam Harvey

Track Other

Keywords

RBX2660

recurrent Clostridioides difficile infection

CDI

pooled safety data

microbiota-based live biotherapeutic

treatment-emergent adverse events

gastrointestinal adverse events

phase 2 and phase 3 studies

placebo-controlled trials

antibiotic-associated microbiome disruption

RBX2660

Safety Profile

Adverse Event

Treatment-Emergent Adverse Event

Severe adverse effect